HHS Template for Reports, with Full Instructions

Regulatory Guide 4.4

Dental Facilities

Consumer Protection Division

Radiation Program

August 2019

Regulatory Guide 4.4

Revised Date: August 2019

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Table of Contents

GUIDE FOR THE PREPARATION OF OPERATING AND SAFETY PROCEDURES FOR

DENTISTRY ........................................................................................ 3

DEPARTMENT INSPECTIONS AND NOTIFICATIONS ................................. 4

REGULATIONS ........................................................................................ 4

REGISTRATION AND FEES ....................................................................... 4

DENTAL EQUIPMENT PERFORMANCE EVALUATIONS (EPE) ..................... 5

RADIATION SAFETY OFFICER (RSO) ....................................................... 5

OPERATOR REQUIREMENTS .................................................................... 6

INDIVIDUAL MONITORING REQUIREMENTS/DOSE TO OPERATORS ....... 6

HOLDING OF PATIENTS AND/OR IMAGE RECEPTOR ............................... 7

POSTING NOTICES, INSTRUCTIONS, REPORTS TO WORKERS, AND POSTING A

RADIATION AREA ............................................................................... 7

OPERATION OF THE X-RAY UNIT ............................................................ 8

DIGITAL IMAGING ACQUISITION SYSTEMS ............................................ 8

FILM PROCESSING ................................................................................ 10

ALTERNATIVE PROCESSING SYSTEMS .................................................. 10

EQUIPMENT INVENTORY ....................................................................... 11

Security and Control of Radiation Machines .......................................... 11

APPENDIX A .......................................................................................... 12

APPENDIX B .......................................................................................... 13

APPENDIX C .......................................................................................... 14

APPENDIX D ......................................................................................... 16

Regulatory Guide 4.4

Revised Date: August 2019

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GUIDE FOR THE PREPARATION OF OPERATING AND

SAFETY PROCEDURES FOR DENTISTRY

Operating and safety procedures are required by 25 Texas Administrative Code (TAC)

§289.232(j)(2). The model procedures in this regulatory guide are generalized. You must

write procedures that are specific for your facility. By using the sections of this guide that apply,

you may create your unique set of operating and safety procedures. This guide may also be used

to develop operating and safety procedures for facilities with mobile services. Although other

formats are acceptable, information contained in §289.232 (j)(2)(B) must be included in your

operating and safety procedures. If you are a sole practitioner and sole operator, and the only

occupationally exposed individual, you are exempt from §289.232(j)(2) and do not have to

maintain operating and safety procedures

Regulatory guides may be reproduced by using the Radiation Control web page at

http://dshs.texas.gov/radiation/x-ray/regulatory-guides.aspx

OPERATING AND SAFETY PROCEDURES FOR:

______________________________________

(Name of Facility)

This manual establishes procedures that will minimize radiation exposure to patients and

employees. These procedures are provided to comply with rules enforced by the Texas

Department of State Health Services (DSHS) Radiation Control. The certificate of registration

contains conditions and restrictions that apply to the operation of the x-ray machines in this

facility as well as a listing of the sections of the rules that apply. These rules are available for

your review in/at [See §289.232].

(specify location)

Regulatory Guides are issued to describe and make available

acceptable methods of implementing specific sections of Title

25 Texas Administrative Code Chapter 289, Texas

Regulations for Control of Radiation, to delineate

techniques used by the staff in evaluating specific issues, or

to provide guidance to applicants, licensees, or registrants.

Regulatory Guides are NOT substitutes for regulations and

compliance with them is not required. Methods and solutions

different from those set out in the guides will be acceptable if

they provide a basis for the Texas Department of State Health

Services, Radiation Control, to make necessary

determinations to issue or continue a license or certificate of

registration.

Comments and suggestions for improvements in these Regulatory

Guides are encouraged at all times and they will be revised, as

appropriate, to accommodate comments and to reflect new

information or experience. Comments should be sent to the Radiation

Policy/Standards/Quality Assurance Group, Texas Department of

State Health Services, P.O. Box 149347 Austin, Tx 78714-9347

Regulatory guides may be reproduced or may be obtained by

contacting the agency at (512) 834-6659 or accessing the Radiation

Control web page at http://dshs.texas.gov/radiation/x-

ray/regulatory-guides.aspx

Regulatory Guide 4.4

Revised Date: August 2019

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DEPARTMENT INSPECTIONS AND NOTIFICATIONS

The department is authorized to perform an inspection of a public or private property to

determine if radiation machines are being used according to the Texas Radiation Control Act,

Health and Safety Code, Chapter 401, requirements of this section, orders, or certificates of

registration issued thereunder regarding radiological working conditions. Department

inspections are not announced.

REGULATIONS

1. The Texas Radiation Control Act, Health and Safety Code, Chapter 401, authorizes DSHS to

develop and enforce rules dealing with the use of radiation sources. Title 25 of the Texas

Administrative Code (TAC) Section §289.232 applies to dental facilities and users of dental

x-ray machines. In order for workers to be aware of the requirements of these regulations,

a copy must be available for them.

2. All operators of dental x-ray machines in this facility are required to read these rules and

understand the requirements and restrictions that apply to using a dental x-ray machine.

3. The rules must be available to operators in physical or electronic form.

4. The Certificate of Registration conditions, restrictions, and sections of rules that apply, and

the text of the Rules are available for review in/at .

(specify location)

REGISTRATION AND FEES

1. Any dental facility that uses intraoral or extraoral radiation machines must register within 30

days after beginning use of the machine [§289.232(i)(1)]. Mobile service operations must

receive authorization prior to conducting services [§289.232(i)(2)].

2. Registrants who are also registered by the agency to receive, possess, acquire, transfer, or

use class IIIb and class IV lasers in dentistry shall also comply with the requirements of

§289.301 of this title (relating to Registration and Radiation Safety Requirements for Lasers

and Intense-Pulsed Light Devices).

3. The fee for a certificate of registration for a facility using only dental radiographic machines is

$370. The fee for a certificate of registration for a facility using Class 3B or Class 4 lasers is

$230. [§289.204(j)]

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DENTAL EQUIPMENT PERFORMANCE EVALUATIONS

(EPE)

1. An Equipment Performance Evaluation (EPE) is required to test that the radiation output from

the dental x-ray machine is at an appropriate level and that the machine is working according

to the manufacturer’s specifications. An EPE is required within 30 days of a machines

installation or within 30 days of service that may change the radiation output of the machine.

[§289.232(j)(5)(J)(i)] Dental machines (intraoral, panoramic or cephalometric) are also

required to have an EPE done every four years. Dental CT systems (those that make a 3D

image) must have an EPE done annually, not to exceed 14 months.[§289.232(j)(5)(J)(ii)]

2. EPE’s may only be performed by service companies authorized by the department with a

certificate of registration. The EPE must be documented and available for review by the

department. The EPE must test the following items [§289.232(j)(5)(J)(v) through (xi)].

The service company technician will also evaluate that the machine meets the requirements

of §289.232(j)(5)

a. Timer accuracy and operation of the exposure switch.

b. Exposure reproducibility.

c. Kilovoltage Accuracy.

d. Tube Stability.

e. Collimation.

f. Entrance Exposure Limits.

3. If an EPE shows that a system fails to meet regulatory specifications, the facility has 30 days

to begin repair and the repair must be completed within 90 days. Exceptions may be

approved by the department.

RADIATION SAFETY OFFICER (RSO)

1. The rule requires that a Radiation Safety Officer (RSO) is designated on the application for

registration. [§289.232(i)(1)(E)]

2. The RSO has the responsibility and authority to assure and enforce safe practices when using

dental radiation machines. RSO’s for dental facilities are expected to have knowledge of the

hazards of working with an x-ray machine, education related to ionizing radiation safety, or

experience in the use of the x-ray machine at the facility.

3. The RSO is responsible for establishing and maintaining operating and safety procedures so

radiation exposure is as low as is reasonably achievable (ALARA). RSO’s are also responsible

for investigating and reporting excessive radiation exposure or any loss of an x-ray machine.

The RSO is considered the person responsible for the radiation safety program of facilities

using x-ray machines. [§289.232(i)(1)(E)(v)]

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4. The RSO listed on the registration for this facility is Direct all

questions and concerns to the RSO. (specify name)

OPERATOR REQUIREMENTS

It is responsibility of the facility to ensure that radiation machines will be operated by individuals

qualified by reason of training and experience to use dental x-ray machines in a safe manner.

[See §289.232(i)(1)(D)] The Texas State Board of Dental Examiners requires dental

assistants and dental hygienists to have appropriate training before they can take dental x-rays

unsupervised. Dental hygienists are considered trained based on their credentials. Dental

Assistants must complete an approved training course and be issued a Dental Assistant

Radiology License by the State Board of Dental Examiners before taking dental x-rays without

supervision.

Please contact the Texas State Board of Dental Examiners at (512)463-6400

(http://tsbde.texas.gov/) for further information.

INDIVIDUAL MONITORING REQUIREMENTS/DOSE TO

OPERATORS

1. Radiation exposure monitoring is not required for personnel operating only dental radiation

machines for dental diagnostic purposes. The annual exposure to dentists, hygienists or

assistants has historically been very low. [See §289.232(e)(7)]

2. However, dental facilities are still required to keep the radiation exposure to workers and the

public below certain limits.

3. All occupational dose limits are found in §289.232(j)(3)(A).

4. A facility that uses dental x-ray machines according to §289.232 should be able to maintain

employee radiation exposure and public radiation exposure to levels well below these limits.

5. A woman may choose to “declare” her pregnancy to her employer so that radiation dose to

the fetus is monitored. Declared pregnant women who are likely to receive a dose from

occupational exposure to radiation in excess of 1 millisievert (100 mrem) during the entire

pregnancy must also use an individual monitoring device. [§289.232(j)(3)(A)(i)(IV)]

6. If a woman voluntarily informs the RSO in writing of her pregnancy, the facility must ensure

that the dose to the embryo/fetus does not exceed 5 millisieverts (0.5 rem) during the entire

pregnancy. It is also recommended that the fetus dose is restricted to no more than 0.5

Millisieverts (50 mrem) per month. [§289.232 (j)(3)(A)(i)(V)]

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HOLDING OF PATIENTS AND/OR IMAGE RECEPTOR

1. When a patient or image receptor must be held in position during a dental x-ray, a facility is

required to use mechanical supporting or restraining devices if and when the exam permits.

[See §289.232(j)(11)] Your written operating and safety procedures must describe when

a mechanical supporting or restraining device cannot be used and also procedures for

selecting who will support or restrain the patient or image receptor.

Holding a patient, image receptor or both is only applicable for the following situations in

this facility:

_____(List Situations)_____ _______________________

_______________________ _______________________

2. Neither patient or employee is allowed to hold the x-ray tube or tube housing assembly

during a dental x-ray exam. The only exceptions are dental x-ray machines designed to be

held during an exposure and only when the operator is following the manufacturer’s

procedures. [§289.232(c)(4)]

POSTING NOTICES, INSTRUCTIONS, REPORTS TO

WORKERS, AND POSTING A RADIATION AREA

1. The following documents must be made available to employees:

a. RC Form 232-1 “Notice to Employees” must be posted so that all employees can read

it.

b. The Certificate of Registration, operating and safety procedures, and any notices of

violations involving radiologic working conditions and corrective actions taken must be

made available to employees.

c. Section §289.232 of the Texas Administrative Code, Title 25 must be made available to

employees.

2. The required documents can be found in/at:

(Specify Location)

3. The room(s) in which the x-ray unit(s) is/are located and operated is a radiation area and is

restricted (choose one of the following sentences).

• The Radiation area is designated by “Caution, Radiation Area” signs.

[§289.232(j)(4)(C)]

---or---

• This facility is not required to post “Caution, Radiation Area” signs because

our operators have continuous surveillance and access controls of the

radiation area. [§289.232(j)(4)(D)]

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OPERATION OF THE X-RAY UNIT

1. No x-rays shall be taken unless ordered by a dentist licensed by Texas State Board of Dental

Examiners. [§289.232(b)(1)(B)]

The following dentists order dental exams at this

facility:

2. The operator shall continually see, hear, and communicate with patient during a dental exam.

[§289.232(j)(11)(C)]

3. The operator shall be positioned so that their exposure is as low as reasonably achievable

and that he/she is at least six feet from the source of radiation or behind a protective barrier.

[§289.232(j)(11)(C)]

4. A technique chart for each dental radiation machine used at the facility shall be posted next

to the control panel or electronically displayed at the control panel. The technique chare

must be used by all operators. [§289.232(j)(5)(A)]

5. Techniques charts are displayed in the vicinity of the control panel of each x-ray machine and

are __(choose the ones that apply: written, electronically displayed, graphically

displayed) _.

DIGITAL IMAGING ACQUISITION SYSTEMS

1. The purpose of digital imaging quality assurance/quality control (QA/QC) is to ensure the

digital image acquisition system is functioning as it was designed to and there has not been

any image degradation that would result in a missed diagnosis or the need for a repeat x-ray

exposure.

2. A QA/QC program consists of tests that are repeated on a regular schedule and done in a

way that is consistent with way the previous test was performed. For example, an image

quality test should be repeated with the same phantom in the same position with the same

technique factors each time.

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3. It is a serious violation to allow a patient, employee, or contractor to be exposed as a test

image subject. All dental radiographs on living humans must be for healing arts purposes

only and taken under the order of a licensed dentist. [§289.232(c)(2)]

4. The facility has two options to meet regulatory requirements a quality assurance program.

a. Use the digital QA/QC procedures established and published by the manufacturer of the

digital imaging system. Note that this may not be the same manufacturer as your

dental x-ray machine.

b. The procedures for the digital imaging system manufacturer QA/QC program must be

included in the operating procedures for the facility.

I. The procedures must include the frequency that the tests are done.

II. The test results must be documented, and the documentation must include the

date the test was done and the initials of who performed the test. Any images

created for QA/QC testing must also be retained for review at the authorized use

location.

c. If a manufacturer’s QA/QC protocol is not available, the facility must establish a written

QA/QC protocol, incorporating the following procedures:

I. The QA/QC protocol shall include image quality testing for, but not limited to,

spatial resolution, noise, artifacts and contrast by using a commercially

purchased testing tool or an inanimate object of at least three varying densities.

II. Test images shall be acquired with each x-ray image receptor at an interval not

to exceed three months.

III. Digital QA/QC testing should be conducted with the same phantom or inanimate

object and the same technical factors (technique) each time.

IV. Test images shall be compared to previous test images to assess degradation of

image quality.

V. If an image test fails, the facility has 30 days to initiate repair of the system and

90 days to complete the repair.

VI. The test results must be documented, and the documentation must include the

date the test was done and the initials of who performed the test. Any images

created for QA/QC testing must also be retained for review at the authorized use

location. [see Appendix D]

5. Protocol for QA/QC was established by (choose which one applies):

. The QA/QC protocol is located

(specify location)

(manufacturer/facility)

6. Records of test(s) will be maintained. The record(s) is/are located in/at

(specify location)

7. Digital QA/QC testing shall never be conducted using a human subject.

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FILM PROCESSING

1. Unexposed film is stored

(describe location and procedures for storage)

2. Films shall be developed by the time and temperature recommended by the x-ray film

manufacturer. Specifications are posted in/at

(specify location)

3. Chemicals will be replaced by

supplier’s recommended interval, which is

according to manufacturer’s or chemical ,

or no longer than 3

months.

4. Safe lights(s) in the film processing/loading area is /are provided under these conditions:

Filter Type ______Bulb Wattage ____Distance from work area ______

5. Light leaks around doors, ceiling, or other openings in the darkroom, shall be reported to the

RSO. Repairs must be initiated within 72 hours and completed within 15 days from the

detection of the fault.

6. Darkroom light leak tests shall be performed at intervals not to exceed 6 months. A record

will be maintained. The record is located in/at . (location)

ALTERNATIVE PROCESSING SYSTEMS

If the facility uses daylight processing systems, laser processors, self-processing film units, or

other alternative processing systems, processing will be done according to the manufacturer’s

recommendations for that processing system.

This facility uses (choose from the following):

o Daylight Processing

o Laser Processors

o Self-processing film systems

o Other: .

The manufacturer’s procedures for using the above system is located at

. [§289.232(j)(13)]

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EQUIPMENT INVENTORY

An inventory of all radiation machines must be taken at an interval not to exceed 1 year and

shall include:

• the manufacturer’s name,

• model and serial number of the control panel, and

• the location of the radiation machine (ex. room name/number).

The yearly inventory of all radiation machines is located at

Security and Control of Radiation Machines

The facility is required to have control procedures in place that prevent an unauthorized person

from operating an x-ray machine or taking an x-ray machine. If an employee is not able to keep

a constant eye on the x-ray machines, then the facility must do something to prevent a patient

or family member from turning the machine on accidentally. If a facility uses handheld dental

machines or portable dental machines, the facility must have procedures that prevent the theft

of x-ray machines. Examples of administrative controls are written procedures to lock doors to

the work area when staff are not present or written procedures to lock a handheld x-ray

machine in a cabinet when not in use. [§289.232(j)(4)(E)]

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APPENDIX A

SAMPLE RECORD FOR INSTRUCTIONS OF INDIVIDUALS

IN OPERATING AND SAFETY PROCEDURES FOR

______________________ (name of facility)

The Operating and Safety Procedures shall be read, signed, and dated by the RSO

and all operators annually. [§289.232(j)(2)(A)]

These procedures have been made available to each individual who operates the x-ray

equipment on the date(s) indicated. [§289.232(j)(2)(A)]

_____________________________________________________________________

(Signature of RSO) (Date)

Equipment Operator Statement:

I have read these procedures and agree to follow them.

_____________________________________________________________________